Treatment of chronic inflammatory disorders of the gastrointestinal tract

Abstract

The present disclosure relates to an oral formulation for treating gastrointestinal inflammation that includes an effective amount of budesonide suspended in an edible oil, typically a vegetable oil. A method for treating gastrointestinal inflammation in mammals is also described and includes orally administering a composition of this invention to a mammal. In one embodiment, an initial dosage is administered daily for about two to four weeks and the dosage is subsequently tapered, generally at about two week intervals, in response to a reduction in symptoms until a minimum dose that controls symptoms is achieved.

What is claimed is: 
     
       1. An oral formulation for treating gastrointestinal inflammation comprising a suspension of an effective amount of budesonide in an edible oil derived from an animal or vegetable. 
     
     
       2. The oral formulation of claim 1 wherein budesonide is present at a concentration of about 1.0 to 2.0 mg/ml. 
     
     
       3. The oral formulation of claim 1 wherein the suspension is a colloidal suspension. 
     
     
       4. The oral formulation of claim 1 wherein the edible oil is a polyunsaturated oil. 
     
     
       5. The oral formulation of claim 1 wherein the edible oil is a vegetable oil. 
     
     
       6. The oral formulation of claim 5 wherein the vegetable oil is selected from the group consisting of avocado oil, olive oil, and safflower oil. 
     
     
       7. The oral formulation of claim 1 wherein the suspension is encapsulated in a controlled-release coating. 
     
     
       8. The oral formulation of claim 7 wherein the controlled-release coating is formulated for release in the small intestine. 
     
     
       9. The oral formulation of claim 7 wherein the controlled-release coating is formulated for release in the large intestine. 
     
     
       10. The oral formulation of claim 7 wherein the controlled-release coating is formulated for release in the stomach. 
     
     
       11. A method for treating gastrointestinal inflammation in a mammal comprising orally administering a suspension comprising an effective amount of budesonide in an edible oil to the mammal. 
     
     
       12. The method of claim 11 wherein the suspension is administered daily for at least four weeks. 
     
     
       13. The method of claim 11 wherein the mammal is a dog and an initial dosage of 0.1 mg/kg of budesonide is administered daily. 
     
     
       14. The method of claim 11 wherein the mammal is a cat and an initial dosage of 0.4 mg/kg of budesonide is administered daily. 
     
     
       15. The method of claim 11 wherein the mammal is a human and an initial dosage of 0.1 mg/kg of budesonide is administered daily. 
     
     
       16. The method of claim 11 wherein an initial dosage is administered twice daily for about two to four weeks and subsequently reduced in response to a reduction in symptoms. 
     
     
       17. The method of claim 16 wherein the dosage is subsequently reduced by about one-third to one-half of the initial dosage. 
     
     
       18. The oral formulation of claim 1 wherein said formulation is substantially free of water. 
     
     
       19. The method of claim 11 wherein said suspension is substantially free of water.